Clinical Trials List
Protocol NumberNBM-BMX-003
NCT Number(ClinicalTrials.gov Identfier)NCT06012695
Active
2023-08-01 - 2027-04-30
Phase I/II
Recruiting4
A Phase Ib/II, Open-label Study of NBM-BMX as Monotherapy or in Combination with Radiotherapy and Temozolomide in Subjects with Solid Tumors or Newly Diagnosed Glioblastoma
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Trial Applicant
Efficient Pharma Management Corp.
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Sponsor
Efficient Pharma Management Corp.
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 李權 Division of Radiation Therapy
- 陳文賢 Division of Radiology
- ZHENG-WEI ZHOU Division of Hematology & Oncology
- 傅景佟 Division of Others
- YU-HSUAN SHIH Division of Hematology & Oncology
- CHENG-HSIEN LIN Division of Hematology & Oncology
- HSIN-CHEN LIN Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Kuo-Chen Wei
Co-Principal Investigator
- Chi-Ting Liau Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Newly Diagnosed Glioblastoma
Objectives
Arm A (monotherapy in advanced solid tumors)
Primary Objective:
• To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) for NBM-BMX monotherapy in subjects
with advanced solid tumors
Secondary Objectives:
• To assess the safety and tolerability of NBM-BMX monotherapy
• To assess the pharmacokinetics (PK) of NBM-BMX Capsule
• To assess the preliminary anti-tumor activity of NBM-BMX monotherapy
Arm B (combination therapy in newly diagnosed glioblastoma)
Primary Objective:
Phase Ib (Dose-escalation)
• To determine the maximum tolerated dose (MTD) or maximum feasible dose (MFD) and recommended Phase 2 dose (RP2D)
for NBM-BMX in combination with radiotherapy (RT) and temozolomide (TMZ) in subjects with newly diagnosed glioblastoma (GBM)
Phase II (Expansion)
• To assess the preliminary efficacy of NBM-BMX in combination with RT and TMZ in subjects with newly diagnosed GBM
Secondary Objectives:
Both Phases
• To assess the safety and tolerability of NBM-BMX in combination with RT/TMZ
• To assess the pharmacokinetics (PK) of NBM-BMX Capsule when combined with RT/TMZ
Exploratory Objective:
Both Phases
• To assess associations between tumor response and various molecular markers
Test Drug
NBM-BMX
Active Ingredient
NBM-BMX
Dosage Form
Capsules
Dosage
100mg
Endpoints
Arm A (advanced solid tumors)
Primary Endpoint:
• Frequency of dose-limiting toxicity (DLT) at each dose level
Arm B (newly diagnosed GBM)
Phase Ib
• Frequency of dose-limiting toxicity (DLT) at each dose level
Phase II
• Progression-free survival rate at 6 months (PFS6)
Primary Endpoint:
• Frequency of dose-limiting toxicity (DLT) at each dose level
Arm B (newly diagnosed GBM)
Phase Ib
• Frequency of dose-limiting toxicity (DLT) at each dose level
Phase II
• Progression-free survival rate at 6 months (PFS6)
Inclution Criteria
Arm A (advanced solid tumors)
1. Having signed and dated the informed consent form.
2. Females or males ≥ 18 years old.
3. Histologically or cytologically confirmed advanced solid tumors refractory to standard
of care therapy, or for which no standard of care therapy is available.
4. Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria (for CNS tumors)
5. ECOG performance status 0 to 2
6. Adequate organ function as defined by the following criteria:
a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), unless liver metastases present, then ≤ 5 x ULN
b. Total serum bilirubin ≤ 1.5 x ULN unless bilirubin elevation is related to Gilbert’s
Syndrome for which bilirubin ≤ 3 x ULN
c. Absolute neutrophil count (ANC) ≥ 1,000/uL
d. Platelets ≥ 75,000/uL
e. Hemoglobin ≥ 8.0 g/dL
f. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 × BSA (m2)/1.73
7. QTcF ≤ 480 msec
8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Arm B (newly diagnosed GBM)
1. Having signed and dated the informed consent form.
2. Females or males ≥18 years old.
3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable or partially resected or resected glioblastoma.
4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.
5. Disease that is measurable or evaluable as defined by Response Assessment in NeuroOncology (RANO) criteria.
6. Adequate organ function as defined by the following criteria:
a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), unless liver metastases present, then ≤ 5 x ULN
b. Total serum bilirubin ≤ 1.5 x ULN unless bilirubin elevation is related to Gilbert’s Syndrome for which bilirubin ≤ 3 ULN
c. Absolute neutrophil count (ANC) ≥ 1,500/uL
d. Platelets ≥ 100,000/uL
e. Hemoglobin ≥ 8.0 g/dL
f. Non-indexed estimated creatinine clearance (eGFR) ≥ 60 mL/min/1.73 m2 × BSA(m2)/1.73
7. QTcF ≤ 480 msec.
8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
1. Having signed and dated the informed consent form.
2. Females or males ≥ 18 years old.
3. Histologically or cytologically confirmed advanced solid tumors refractory to standard
of care therapy, or for which no standard of care therapy is available.
4. Disease that is measurable or evaluable as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria (for CNS tumors)
5. ECOG performance status 0 to 2
6. Adequate organ function as defined by the following criteria:
a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3 x upper limit of normal (ULN), unless liver metastases present, then ≤ 5 x ULN
b. Total serum bilirubin ≤ 1.5 x ULN unless bilirubin elevation is related to Gilbert’s
Syndrome for which bilirubin ≤ 3 x ULN
c. Absolute neutrophil count (ANC) ≥ 1,000/uL
d. Platelets ≥ 75,000/uL
e. Hemoglobin ≥ 8.0 g/dL
f. Non-indexed estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2 × BSA (m2)/1.73
7. QTcF ≤ 480 msec
8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Arm B (newly diagnosed GBM)
1. Having signed and dated the informed consent form.
2. Females or males ≥18 years old.
3. Newly diagnosed, histologically confirmed glioblastoma, non-resectable or partially resected or resected glioblastoma.
4. Karnofsky performance status (KPS) ≥ 60 at screening and before the initiation (Day 1) of concomitant therapy.
5. Disease that is measurable or evaluable as defined by Response Assessment in NeuroOncology (RANO) criteria.
6. Adequate organ function as defined by the following criteria:
a. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤ 3 x upper limit of normal (ULN), unless liver metastases present, then ≤ 5 x ULN
b. Total serum bilirubin ≤ 1.5 x ULN unless bilirubin elevation is related to Gilbert’s Syndrome for which bilirubin ≤ 3 ULN
c. Absolute neutrophil count (ANC) ≥ 1,500/uL
d. Platelets ≥ 100,000/uL
e. Hemoglobin ≥ 8.0 g/dL
f. Non-indexed estimated creatinine clearance (eGFR) ≥ 60 mL/min/1.73 m2 × BSA(m2)/1.73
7. QTcF ≤ 480 msec.
8. Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures.
Exclusion Criteria
Arm A (advanced solid tumors)
1. Systemic anti-cancer treatment (investigational or approved) within 28 days or 5 halflives of that drug (whichever is shorter) before the first dose of NBM-BMX.
2. Curative radiation therapy or major surgery within 28 days or palliative RT within 7 days before the first dose of NBM-BMX.
3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
4. Any of the following within 6 months before the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart
failure, or cerebrovascular accident including transient ischemic attack.
5. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
6. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
8. Females who are pregnant or breastfeeding.
9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risks associated with study participation or study drug administration.
10. Major surgical procedures (as defined by Investigator) within 28 days before the first dose of NBM-BMX or having any ongoing post-operative complications.
11. A history of another primary cancer within 5 years. However, subjects with carcinoma in situ of any origin are not excluded.
12. Difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
13. A history of allergic reactions to excipients used in NBM-BMX Capsule.
Arm B (newly diagnosed GBM)
1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
3. Corticosteroid use of > 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.
4. A history of hypersensitivity reaction to temozolomide or dacarbazine.
5. Any of the following within 6 months before the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure,
or cerebrovascular accident including transient ischemic attack.
6. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
8. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period and for at least 6 months after the final dose of temozolomide.
Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
9. Female who are pregnant or breastfeeding.
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator and/or sponsor, excess risks associated with study participation or study drug administration.
11. A history of another primary cancer within 5 years. However, subjects with carcinoma insitu of any origin are not excluded.
12. Difficulty swallowing (including those require nasogastric tube) or with impaired
absorption of oral medications.
13. A history of allergic reactions to excipients used in NBM-BMX Capsule.
1. Systemic anti-cancer treatment (investigational or approved) within 28 days or 5 halflives of that drug (whichever is shorter) before the first dose of NBM-BMX.
2. Curative radiation therapy or major surgery within 28 days or palliative RT within 7 days before the first dose of NBM-BMX.
3. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
4. Any of the following within 6 months before the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart
failure, or cerebrovascular accident including transient ischemic attack.
5. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
6. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
7. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period.
Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
8. Females who are pregnant or breastfeeding.
9. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgement of the investigator and/or sponsor, excess risks associated with study participation or study drug administration.
10. Major surgical procedures (as defined by Investigator) within 28 days before the first dose of NBM-BMX or having any ongoing post-operative complications.
11. A history of another primary cancer within 5 years. However, subjects with carcinoma in situ of any origin are not excluded.
12. Difficulty swallowing (including those require nasogastric tube) or with impaired absorption of oral medications.
13. A history of allergic reactions to excipients used in NBM-BMX Capsule.
Arm B (newly diagnosed GBM)
1. Prior systemic therapy (including Gliadel wafer implant), immunotherapy, investigational agents, or radiotherapy for glioblastoma.
2. Currently taking strong inhibitors (e.g., gemfibrozil) or inducers of CYP2C8.
3. Corticosteroid use of > 8 mg/day dexamethasone or equivalent within 5 days before the first dose of NBM-BMX.
4. A history of hypersensitivity reaction to temozolomide or dacarbazine.
5. Any of the following within 6 months before the first dose of NBM-BMX: pulmonary embolism events, deep vein thrombosis (DVT) events, myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure,
or cerebrovascular accident including transient ischemic attack.
6. A positive test for hepatitis B (HBsAg) and/or hepatitis C (anti-HCV antibody), unless the HBV DNA level and/or HCV RNA level is below the limit of detection.
7. Known history of human immunodeficiency virus (HIV) infection. Note: HIV testing is not required.
8. Men and women of childbearing potential who are unwilling to use highly effective contraceptive methods during the study period and for at least 6 months after the final dose of temozolomide.
Highly effective contraceptive methods include implants, injectables, combined oral contraceptives, intra-uterine devices (IUDs), sexual abstinence, surgical sterilization or a partner who is sterile.
9. Female who are pregnant or breastfeeding.
10. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would impart, in the judgment of the investigator and/or sponsor, excess risks associated with study participation or study drug administration.
11. A history of another primary cancer within 5 years. However, subjects with carcinoma insitu of any origin are not excluded.
12. Difficulty swallowing (including those require nasogastric tube) or with impaired
absorption of oral medications.
13. A history of allergic reactions to excipients used in NBM-BMX Capsule.
The Estimated Number of Participants
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Taiwan
79 participants
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Global
79 participants
